Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
Primary Purpose
Cellulitis of Leg
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics
Sponsored by
About this trial
This is an interventional treatment trial for Cellulitis of Leg focused on measuring cellulits of leg, Motorized power massage, massage
Eligibility Criteria
Inclusion Criteria:
- Female gender, over 18 years of age;
- With a body mass index up to 29.9 considered overweight;
- Carriers of GI lipodystrophy;
- Non smokers;
- That they agree to participate and sign the term of free and informed commitment - TCLE
Exclusion Criteria:
- Male gender;
- Performed esthetic treatment in the gluteal region and thighs in the last month;
- Patients with skin lesions, such as dermatitis and dermatoses;
- Patients with capillary fragility;
- Patients with acute deep vein thrombosis (DVT);
- On or near cancerous lesions;
- Patients with cardiac pacemaker or other implanted electronic device.
Sites / Locations
- Ibramed - Indústria Brasileira de Equipamentos MédicosRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention of mechanical massage with cosmetics
Arm Description
Patients will be treated with motorized mechanical massage and associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.
Outcomes
Primary Outcome Measures
Anthropometric evaluation
BMI (kg / height m2)
Anthropometric evaluation
Perimeter in the region to be treated in centimeters.
Evaluation of the degree of cellulite
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Assessment of adipose tissue thickness
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Assessment of skin elasticity
Evaluation of skin elasticity (Cutometer® MPA580)
Secondary Outcome Measures
Full Information
NCT ID
NCT03199781
First Posted
May 19, 2017
Last Updated
June 24, 2017
Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
1. Study Identification
Unique Protocol Identification Number
NCT03199781
Brief Title
Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
Official Title
Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
August 20, 2017 (Anticipated)
Study Completion Date
September 15, 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indústria Brasileira Equipamentos Médicos - IBRAMED
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
PURPOSE: To evaluate the efficacy of motorized mechanical massage associated with cosmetics in improving body contour and appearance of gynoid lipodystrophy.
SUBJECTS AND METHODS: A prospective and comparative longitudinal clinical study will be performed in 30 women with localized fat and gynoid lipodystrophy. Patients will be submitted data collection and assessments and before and after treatment.
HYPOTHESES: It is expected that the patients will present improvement in the body contour and in the picture of the gynoid lipodystrophy after the association of the therapies.
STATISTICAL ANALYSIS: A descriptive analysis will be done before and after vibration-oscillatory therapy, with frequency tables for categorical and descriptive variables (mean, standard deviation, median, minimum and maximum values) for continuous or numerical variables. In order to compare the main variables between the groups and the collection times, the analysis of variance (ANOVA) for repeated measurements will be used. Tukey's test will be used to compare groups. The level of significance adopted for the statistical tests will be 5% or p <0.05.
Detailed Description
After signing the informed consent, the participants will be evaluated by two physiotherapists where the data collected will be from personal data, anthropometric and complementary diagnostic tests such as: ultrasound diagnosis in order to evaluate the thickness of the adipose tissue and Cutomiter analysis of the Viscoelasticity of the skin. Afterwards they will be divided and started the treatment with another physiotherapist who will perform the following protocol of the study: exfoliation of the skin, application of the motorized mechanical massage with the device Dermotonus Slim with 550mg of vacuum, continuous mode, for 20 minutes subdivided into region Abdominal and posterior thigh, after the end will be applied the creams for lipolytic purposes. The protocol will be performed twice a week for 1 hour each, totaling 10 sessions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cellulitis of Leg
Keywords
cellulits of leg, Motorized power massage, massage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention of mechanical massage with cosmetics
Arm Type
Experimental
Arm Description
Patients will be treated with motorized mechanical massage and associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.
Intervention Type
Device
Intervention Name(s)
Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics
Intervention Description
Patients will be treated with motorized mechanical massage with the Dermothonus Slim® electromedical equipment (Ibramed- Brazilian Industry of Electrical Equipment) associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.
Primary Outcome Measure Information:
Title
Anthropometric evaluation
Description
BMI (kg / height m2)
Time Frame
Ten minutes
Title
Anthropometric evaluation
Description
Perimeter in the region to be treated in centimeters.
Time Frame
Ten Minutes
Title
Evaluation of the degree of cellulite
Description
Assessment of Gland Lipodystrophy: Cellulite Severity Scale (CSS). Photographic study.
Time Frame
Ten minutes
Title
Assessment of adipose tissue thickness
Description
Assessment of the thickness of the dermis or hypodermis (Ultrasound diagnosis)
Time Frame
Twenty minutes
Title
Assessment of skin elasticity
Description
Evaluation of skin elasticity (Cutometer® MPA580)
Time Frame
Twenty minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female gender, over 18 years of age;
With a body mass index up to 29.9 considered overweight;
Carriers of GI lipodystrophy;
Non smokers;
That they agree to participate and sign the term of free and informed commitment - TCLE
Exclusion Criteria:
Male gender;
Performed esthetic treatment in the gluteal region and thighs in the last month;
Patients with skin lesions, such as dermatitis and dermatoses;
Patients with capillary fragility;
Patients with acute deep vein thrombosis (DVT);
On or near cancerous lesions;
Patients with cardiac pacemaker or other implanted electronic device.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renata M Guidi
Phone
38179633
Email
re_guidi@yahoo.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Débora Modena
Phone
019991319016
Email
de_modena@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Débora modena
Organizational Affiliation
University of Campinas, Brazil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ibramed - Indústria Brasileira de Equipamentos Médicos
City
Amparo
State/Province
São Paulo
ZIP/Postal Code
13901-080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Débora Modena, MsC
Phone
19991319016
Email
de_modena@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Caroline Silva
Phone
01938179633
Email
de_modena@yahoo.com.br
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
9502849
Citation
Chang P, Wiseman J, Jacoby T, Salisbury AV, Ersek RA. Noninvasive mechanical body contouring: (Endermologie) a one-year clinical outcome study update. Aesthetic Plast Surg. 1998 Mar-Apr;22(2):145-53. doi: 10.1007/s002669900182.
Results Reference
result
PubMed Identifier
11420530
Citation
Adcock D, Paulsen S, Jabour K, Davis S, Nanney LB, Shack RB. Analysis of the effects of deep mechanical massage in the porcine model. Plast Reconstr Surg. 2001 Jul;108(1):233-40. doi: 10.1097/00006534-200107000-00038.
Results Reference
result
PubMed Identifier
16401454
Citation
Gordon C, Emiliozzi C, Zartarian M. Use of a mechanical massage technique in the treatment of fibromyalgia: a preliminary study. Arch Phys Med Rehabil. 2006 Jan;87(1):145-7. doi: 10.1016/j.apmr.2005.08.125.
Results Reference
result
PubMed Identifier
18719762
Citation
Milani GB, Natal Filho A, Amado Joao SM. Correlation between lumbar lordosis angle and degree of gynoid lipodystrophy (cellulite) in asymptomatic women. Clinics (Sao Paulo). 2008 Aug;63(4):503-8. doi: 10.1590/s1807-59322008000400015.
Results Reference
result
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Motorized Mechanical Massage Associated With Cosmetics in Improving Body Contour and Appearance of Gynoid Lipodystrophy
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